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What is preemption in a pharmaceutical liability case?


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This blog has spent some time discussing the major role the federal Food and Drug Administration plays in regulating the safety of pharmaceutical products in Texas and the rest of the United States. The FDA not only monitors the way companies research, produce and bring drugs to market, but it also approves various uses and warnings of potential side effects of medicines sold throughout the country. While these are important and necessary functions to affect consumers, pharmaceutical manufacturers have used the existence of this regulatory body to attempt to avoid liability for injuries caused by their products.

One way this is done in defective warnings cases is by defending manufacturers asserting what is known as the ‘federal preemption doctrine.’ This doctrine is based on the supremacy clause of the U.S. Constitution, which generally says that when federal and state laws conflict, federal law applies. At a very basic level, the argument these companies make is that if the FDA has approved a warning for a certain drug, the manufacturer cannot be held liable for a defect in the warning even if state law standards would allow it.

While there have been many conflicting court cases regarding this very complicated issue, two Supreme Court Of The United States decisions may be relevant to consumers. In one, the Court held that name-brand manufacturers of drugs cannot argue preemption to avoid defective warnings claims just because there were FDA approved warnings, unless the company could show by clear evidence that any proposed warning change would have been rejected by the FDA. In the other, SCOTUS found that producers of generic drugs, on the other hand, generally may use the preemption doctrine to avoid liability in defective warnings cases.

Again, this is an area of law that is immensely complex and constantly changing, like much of the pharmaceutical liability area. However, people should be aware of the lengths pharmaceutical manufacturers may go to avoid paying for injuries caused by their products. People injured by taking a medicine that was supposed to help may wish to consider looking into the services of an experienced liability attorney.

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